Catalog Number

-

Brand Name

Diabetic Specialty Solutions

Version/Model Number

66990

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CEN

Product Code Name

Dye-Indicator, Ph (Urinary, Non-Quantitative)

Public Device Record Key

6891111b-1a4a-4b3d-aaa9-080a62c294dd

Public Version Date

September 18, 2020

Public Version Number

1

DI Record Publish Date

September 10, 2020

Package DI Number

20025715669902

Quantity per Package

6

Contains DI Package

00025715669908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag